Peroral dosage form for peptide containing medicaments, in particular insulin

Abstract

There is provided a plural dosage form for peptide pharmaceuticals comprising a matrix of gelatin or gelatin derivative having distributed therein the peptide pharmaceutical in particular insulin, as well as, pharmaceutically conventional carriers and additives. By selection of the appropriate gelatin the pharmaceutical is liberated in the small intestine or the large intestine so that is not enzymatically degraded anymore by peptidases.

What is claimed is:  
     
       1. Dry pellets containing peptide pharmaceuticals, in oral, buccal, sublingual or nasally administrable dosage form comprising at least one peptide pharmaceutical having a given net charge dispersed in a matrix which comprises 
       a member seldBted from the froup consisting of gelatin, fractionated gelatins, collagen hydrolysates, crosslinked gelatins and mixtures thereof,  
       said member or members of said group of hydrophilic molecules carrying a sufficient contrary net charge to form a psuedocoazervate with said peptide pharmaceutical.  
     
     
       2. Dry pellets of  claim 1  wherein said peptide is dispersed in a matrix whose component molecules are insoluble in aqueous media below 37° C. 
     
     
       3. Dry pellets of  claim 1  wherein said peptide pharmaceutical is insulin. 
     
     
       4. Dry pellets of  claim 1  wherein the major portion of the gelatin has a molecular weight distribution between 9×10 4  and 10 7  D. 
     
     
       5. Dry pellets of  claim 1  wherein said peptide pharmaceutical is substantially microencapsulated in gelatin. 
     
     
       6. Peroral dosage form for a peptide pharmaceutical in accordance with  claim 2 , wherein the gelatin has a bloom value of between 30 and 320, the fractioned gelatins, when present, have a molecular weight exceeding 9.5×10 4  D, and the cllagen hydrolysates, when present, have a molecular weight between 100 and 9.5×10 4  D. 
     
     
       7. Dry pellets of  claim 1  having a synthetic or natural coating. 
     
     
       8. Peroral dosage form for a peptide pharmaceutical wherein the dry pellets of  claim 7  are provided as coated tablets. 
     
     
       9. Peroral dosage form for a peptide pharmaceutical of  claim 7  wherein slow dissolving forms are combided with rapid dissolving forms. 
     
     
       10. Peroral dosage form for a peptide pharmaceutical in accordance with  claim 9  in tablet form, having a first, outward-most coated layer in delayed release form and a second coated layer in rapid release form.